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Dosing of 3-Factor Prothrombin Complex Concentrate for International Normalized Ratio Reversal

Dosing of 3-Factor Prothrombin Complex Concentrate for International Normalized Ration Reversal

Baggs JH, Patanwala AE, Williams EM, Erstad BL.  Ann Pharmacother.  2012;46:51-6.


Study Question:  What is the optimal dosing strategy of 3-factor prothrombin complex concentrates (PCC) to achieve adequate international normalized ratio (INR) reversal?


Study Description:  Researchers conducted a retrospective cohort study involving consecutive patients who received PCC (Profiline SD®) to reverse INR values > 2.  Patients were stratified into groups, adequate reversal with final INR ≤ 1.5 or inadequate reversal with final INR > 1.5 with final INRs measured 1.5 hours after PCC dose.  The primary outcome was the difference in initial INR between adequately and inadequately reversed groups.  Dosing of PCC was based on provider preference.


Results:  A total of 50 patients were included in the analyses after meeting inclusion criteria, of which 82% had received warfarin.  Results showed that 58% of patients achieved adequate INR reversal while 42% had inadequate reversal after receiving PCC.  The median initial doses of PCC were similar between both groups (24.5-25.2 units/kg), and those who had inadequate INR reversal proved to have significantly higher median baseline INRs (3.5 vs. 2.5, p = 0.01) prior to PCC administration.  The administration of vitamin K, fresh frozen plasma, platelet, and cryoprecipitate was not different between groups.  The administration of packed red blood cells was significantly higher in the group with inadequate INR reversal, but it did not result in any significant differences between groups in hemoglobin and hematocrit value changes between baseline and 24 hours post-PCC administration.


Conclusion(s):  Investigators conclude that patients with a higher baseline INR are less likely to achieve adequate INR reversal after receiving similar doses of 3-factor PCC and may require higher doses (50 units/kg).


Perspective:  Higher doses of PCC may be associated with a higher risk of thromboembolic complications and will increase direct costs.  Further studies are needed to determine the initial INR value at which higher 3-factor PCC doses (50 units/kg) should be recommended.  Guidelines presently recommend a dose of 25-50 units/kg.


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